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COVID-19

EU medicines agency gives green light to second Covid-19 vaccine

The European Medicines Agency has given its approval to the Moderna Covid-19 vaccine, paving the way for it to be rolled out across the EU.

EU medicines agency gives green light to second Covid-19 vaccine
Moderna vaccine has been given green light by the EMAAFP

On Wednesday the European Medicines Agency (EMA) announced it had approved the Moderna vaccine in the fight against Covid-19.

It follows approval last month for the Pfizer-BioNTech vaccine that is in the process of being rolled out across the EU.

The final authorisation for the Moderna vaccine will need to be granted by the EU Commission.

Commission chief Ursula von der Leyen described the announcement as “good news”.

“Now we are working at full speed to approve it and make it available in the EU,” she added.

“This vaccine provides us with another tool to overcome the current emergency,” said Emer Cooke, Executive Director of EMA. “It is a testament to the efforts and commitment of all involved that we have this second positive vaccine recommendation just short of a year since the pandemic was declared by WHO.

The approval also clears the vaccine for use in Norway and Iceland, which are signed up to the EU's procurement scheme.

 

The vaccine will help governments across the EU battle against Covid-19 infections which have remained high throughout December and forced many countries to introduce further restrictions.

Background

COVID-19 Vaccine Moderna is given as two injections into the arm, 28 days apart. The most common side effects with COVID-19 Vaccine Moderna were usually mild or moderate and got better within a few days after vaccination.

A very large clinical trial showed that COVID-19 Vaccine Moderna was effective at preventing COVID-19 in people from 18 years of age. 

The trial involved around 30,000 people in total. Half received the vaccine and half were given dummy injections. People did not know whether they received the vaccine or the dummy injections.

Efficacy was calculated in around 28,000 people from 18 to 94 years of age who had no sign of previous infection. 

 

The trial showed a 94.1% reduction in the number of symptomatic COVID-19 cases in the people who received the vaccine (11 out of 14,134 vaccinated people got COVID-19 with symptoms) compared with people who received dummy injections (185 out of 14,073 people who received dummy injections got COVID-19 with symptoms). This means that the vaccine demonstrated a 94.1% efficacy in the trial.

Since November 9th, four manufacturers have announced that their vaccine is effective: Pfizer-BioNTech, Moderna, the British alliance AstraZeneca-University of Oxford and the Russian state institute Gamaleia.

These announcements are based on phase 3 clinical trials that involve tens of thousands of volunteers. 

The scientific journal The Lancet confirmed on December 8 that AstraZeneca's vaccine was 70 percent effective on average. 

The FDA confirmed the Pfizer-BioNTech vaccine at 95 percent efficacy with Moderna claiming 94.1 percent for its drug. Russia claims a 91.4 percent efficacy for its Sputnik V vaccine.

The AstraZeneca-Oxford vaccine is the least expensive at around €2.50 per dose. The vaccines from Moderna and Pfizer/BioNTech have a logistical handicap, as they can only be stored over the long term at very low temperatures (-20° Celsius for the former, -70°C for the latter). 

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COVID-19

Health experts advise end of masks on public transport in Spain

Spanish health experts have advised the government that the use of masks should no longer be obligatory on public transport, but no concrete date has yet been set.

Health experts advise end of masks on public transport in Spain

Health experts who advise the Spanish Ministry of Health have said that masks should no longer be mandatory on public transport, but with the caveat that the government should first wait and observe the epidemiological situation in China, which has experienced a surge in case numbers since it abandoned its strict ‘Zero Covid’ strategy at the end of 2022, following widespread civil unrest.

The use of masks on public transport has now been the norm in Spain for almost three years, since the start of the pandemic. 

Speaking to Ser Canarias, Darias said: “We are getting closer and closer [to the end of having to wear a mask], but we will have to see how things evolve in order to make that decision; obviously the epidemiological situation is getting better and better, but we have to see how the issue of China evolves”. 

Reports in the Spanish press suggest some kind of agreement was made during a meeting between the government and the experts in December that masks would no longer be compulsory after assessing the situation in China, however, there is still no fixed date.

Back in October 2022, Spain’s ‘Emergency Unit’ suggested that mask rules would not be reviewed until March 2023 at the earliest, but more recently it said that it does not seem necessary to wait for March to remove the mask rule. 

According to recent Ministry of Health figures, just 2.79 percent of hospital beds in Spain are taken up by Covid-19 patients.

READ ALSO: Face masks to remain mandatory on public transport in Spain until March 2023

The use of masks indoors in Spain ceased to be mandatory on April 20th, 2022, after almost two years, however, they have remained mandatory in hospitals, pharmacies and, crucially, also on buses, metro, trains, planes and taxis.

While the mask rules have been strictly enforced in some places in Spain such as Seville and Valencia, in other cities such as Barcelona, many people refuse to wear them, despite the regulations still officially being in place. 

READ ALSO: Spain now requires Covid certificates for arrivals from China

In China, figures suggest that almost 60,000 people have died as a result of Covid-19 in a single month amid the spike in cases following the end of the country’s draconian restrictions. In response, Spain reintroduced health control checks for travellers arriving from China. 

It seems that Darias and the Spanish government are waiting to see how the situation plays out in China first, but all the indications and expert advice seems to suggest that masks will no longer be mandatory in public transport sometime very soon. 

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